This invention is directed to therapeutic procedures for a patient's heart and to instruments and systems for such procedures. The procedures and the instruments and systems for such procedures are particularly suitable for treating that patient suffering from the symptoms of congestive heart failure (CHF), and particularly to those CHF patients exhibiting mitral valve regurgitation (MVR) and/or those exhibiting intraventricular conduction delay with resulting disturbance of the synchronous right and/or left ventricular contractility.
There are over five million patients in the United States suffering from congestive heart failure and there are more than seven hundred thousand new cases each year. For many of these patients medical therapy is not very successful. Recent trials have shown that a significant number of CHF patient's benefit from percutaneous ventricular pacing where pacing leads are introduced percutaneously and advanced within the patient's vasculature until the leads are disposed within the patient's coronary sinus. However, ventricular pacing has not been found successful for a significant number of CHF patients for a variety of reasons. For example, in a number of procedures the coronary sinus cannot be cannulate and even if cannulated, the leads can become displaced.
With many CHF patients, their ventricular ejection fraction is reduced due to mitral valve regurgitation (MR) resulting from dilated cardiomyopathy, which is the deformity of the heart which accompanies CHF. The MR in turn can exacerbate the cardiomyopathy leading to a worsening of the MR. The MR can also be the result of torn cordae tendenae which can also prevent complete closure of the valve.
Surgical procedures for mitral valve repair for MR typically involves valve support ring at the base of valve. Recent advances in valve repair include securing together the free edges of the mitral valve leaflets by sutures staples and the like, commonly called “Bow-Tie” or “edge to edge” techniques. These procedures usually involve open heart surgery including cardiopulmonary bypass and a sternotomy, although more recently some of these procedures have been performed by minimally invasive and percutaneous techniques which can reduce the morbidity of such procedures. Percutaneous procedures impose difficulties in instrument design because the instruments for such procedures must be long enough, have small enough profile and have sufficient flexibility for advancement through the patient's vasculature into the patient's heart chamber. However, they must also be able to accurately locate the operative ends of such instruments at a desired location within the chambers of the patient's beating heart and be strong enough to perform the required functions.
Techniques for Bow-Tie repair of mitral valves have been mentioned in the patent literature, but specific instruments for such techniques are not yet commercially available.